QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
NCT ID: NCT00807612
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2009-01-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Cohort 1
AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1
AMG 479
AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1
Carboplatin
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
Paclitaxel
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Part 1 Cohort 2
AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1
AMG 479
AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1
Carboplatin
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
Paclitaxel
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Part 2
AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1
(AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)
Carboplatin
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
AMG 479
AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1
Paclitaxel
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Interventions
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AMG 479
AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1
AMG 479
AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1
Carboplatin
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
AMG 479
AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1
Paclitaxel
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Eligibility Criteria
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Inclusion Criteria
* Measurable disease as defined per modified RECIST criteria
* ECOG performance status of 0 or 1
* ≥18 years old
* Adequate glycemic function, for subjects with known diabetes
Exclusion Criteria
* Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
18 Years
ALL
No
Sponsors
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NantCell, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Fayetteville, Arkansas, United States
Research Site
Fayetteville, Arkansas, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Lafayette, Indiana, United States
Research Site
Lafayette, Indiana, United States
Research Site
New Albany, Indiana, United States
Research Site
New Albany, Indiana, United States
Research Site
Paducah, Kentucky, United States
Research Site
Paducah, Kentucky, United States
Research Site
St Louis, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Memphis, Tennessee, United States
Research Site
Madison, Wisconsin, United States
Research Site
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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QUILT-2.017
Identifier Type: OTHER
Identifier Source: secondary_id
20080257
Identifier Type: -
Identifier Source: org_study_id
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